The TMJ connects the lower jaw (mandible) to the temporal bone in the skull. A person may have an implant to replace the socket in the temporal bone or the rounded edge of the lower jaw that glides in the temporal bone socket because of an injury, arthritis, physical abnormality, or lost mobility.
The three manufacturers, TMJ Solutions, TMJ Medical, and Biomet Microfixation, make all of the currently approved TMJ devices marketed in the United States. The companies will have 30 days to submit a study plan which will need to be approved by the agency before any postmarket studies can begin.
TMJ implants also can be used to treat temporomandibular disorder (TMD) that has not responded to more conservative treatments such as limiting jaw movement, soft diet, jaw splint or adjustments, medicine to reduce pain, or physical therapy.
The FDA analyzed TMJ implant-related adverse event reports submitted between April 30, 2004 and Aug. 17, 2010. The analysis described a substantial number of patients who had implants replaced within three years or less after implantation because of extreme pain. This is considerably shorter than the expected minimum five-year life span of the device, based on premarket mechanical testing.
The TMJ implant postmarket surveillance studies must address the following:
Time between initial implant and removal/replacement
Association between patient diagnosis and the timeframe between implant and removal/replacement
For replacement implants, the time between implant and subsequent removal/replacement
Reasons for removal/replacement of the implant
Associations between patient demographic and clinical data and the need or removal/replacement
Assessment of devices that have been removed from patients
As part of its review, the FDA will consider whether labeling changes, additional preclinical and clinical testing requirements, or other regulatory actions are necessary for these devices.